Clinical Trials Logo

Clinical Trial Summary

The investigators aim will be to compare the diagnostic performance of clinical visual examination (ICDAS II), intraoral/bite wing radiography (BW), near infrared light transillumination (NIR-LT), and laser fluorescence (LF), in comparison to microcomputed tomography (micro-CT) for the detection of non-cavitated occlusal enamel and dentin caries in third molar teeth. Potential participants will be consecutively recruited.

Clinical Trial Description

Studies regarding comparison of diagnostic techniques for caries detection are generally conducted under in vitro conditions due to ethical concerns. Considering the many recently published in vitro studies which attempted to assess the diagnostic ability of different caries diagnosis systems, it is not possible to know at what rate in vitro findings are applicable to the clinical situation.The investigators would like to assess initial occlusal caries lesions by using different diagnostic methods under in vivo conditions. In the present study, the investigators will assess diagnostic accuracy of clinical visual examination (ICDAS II), digital intraoral radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), by examining third molar teeth in comparison to gold standard micro-CT images. The null hypothesis of the study is that no significant difference exists for the clinical performance of the evaluated methods in detecting non-cavitated occlusal caries in either the enamel or the dentin. This prospective study will include 101 third molars of 101 patients with non-cavitated occlusal caries requiring extraction. ICDAS II, BW, NIR-LT and LF examinations will be carried out by two examiners. Gold standard will be determined by micro-CT imaging after extraction. Intraclass correlation coefficient (ICC) value will be calculated for examiner agreement. Accuracy rate, sensitivity, specificity, predictive values and areas under receiver operating characteristic curves (Az) will be calculated. Clinical application time and patient comfort/pain analysis will be compared. Nonparametric variables will be assessed by Kruskal Wallis Test. Significance level will be set at p<0.05. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05064566
Study type Observational
Source Mersin University
Contact Nazan Koçak Topbas, PhD
Phone +905458297898
Email [email protected]
Status Not yet recruiting
Start date October 20, 2021
Completion date December 20, 2022

See also
  Status Clinical Trial Phase
Completed NCT03080623 - Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Completed NCT03073746 - Google Health Search Trial N/A
Recruiting NCT04168983 - Impact of Sophrology on the Pain Felt During a Bone Marrow Aspiration and Biopsy N/A
Recruiting NCT05043662 - UroCAD Assay Combined With Computed Tomography Urography and Urine Cytology for UTUC Diagnosis.
Not yet recruiting NCT04056273 - Assess the Use of rEBUS With a Guide Sheath to Increase Transbronchial Lung Biopsy Yield Rate N/A
Completed NCT03193671 - Evaluation and Implementation of New Biomarkers and Algorithms for Diagnosis of Ovarian Cysts/Tumors in the Pelvis N/A
Recruiting NCT03210311 - Pre-existing Factors, Early Detection and Early Treatment of Breast Cancer Related Lymphedema N/A
Recruiting NCT04299412 - Diagnostic Accuracy of the DPP II Assay
Recruiting NCT04109625 - Preliminary Validation of an in Vitro Diagnosis-medical Device for Hepatitis B Screening N/A
Recruiting NCT03347630 - Pre-operative MRI of Esophagus Cancer N/A
Withdrawn NCT04035174 - Evaluation of the Diagnosis Performances of DEC LTS-2 Skin Patch for Onchocerciasis in Central Africa N/A
Not yet recruiting NCT05047315 - Evaluating a New Stool Based qPCR for Diagnosis of Tuberculosis in Children and People Living With HIV
Completed NCT04541160 - Ultra-low Dose Chest Computed Tomography: a Rule-out Tool for Community-acquired Pneumonia
Completed NCT04315207 - Breaking Potentially Bad News in Lung Cancer Workup: Telephone Versus In-person Breaking of Final Diagnosis N/A
Completed NCT04788966 - Evaluation of an Innovative Speech-enabled Translator in Emergency Settings
Active, not recruiting NCT04547023 - Fasting Versus Fed: Effect of Oral Intake Prior to the Glucose Tolerance Test in Pregnancy N/A
Completed NCT04069104 - Whack-a-Mole: Testing an Intervention to Increase Melanoma Identification
Recruiting NCT04536220 - Establish Diagnostic Models Based on Portal Venous Blood for Pancreatic Cancer
Recruiting NCT04212286 - Comparing the Diagnostic Efficiencies of CEUS and EOB-MRI in Patients With High Risk of HCC N/A
Recruiting NCT03555643 - Evaluation of the HARM for the Detection of a Cerebral Ischemia in TIA/TNA Patients